Title Of Study: [Add the Title of the study here]
Principal Investigator:[Add the PI’s name here]
(This consent form is for confidential data collection for research projects involving the use of mobile devices or electronic technologies. This consent form is provided to the investigator as a guide and should be revised to include relevant details about the given study. Instructions and sample language are noted in boldfaced italics within the brackets [ ]. These instructions along with the sample language must be removed. *Your protocol must describe any detailed protections/transmission procedures*).
CONSENT FORM TO TAKE PART IN A
MOBILE/ELECTRONIC DEVICE OR TECHNOLOGY STUDY
Invitation:
You are invited to participate in a research study that is being conducted by ______[add name(s)], who is a ______[e.g., student, professor, etc.] in the _____ [Department, School, Unit] at Rutgers University. This consent form is part of an informed consent process for a research study and it will provide information that will help you to decide whether you wish to volunteer for this research study. It will help you to understand what the study is about and what will happen in the course of the study.
If you have questions at any time during the research study, you should feel free to ask them and should expect to be given answers that you completely understand. After all of your questions have been answered, if you still wish to take part in the study, you will be askedto sign this informed consent form.
Purpose of Study:
The purpose of this research study is to determine ______[please complete].Approximately ___ [please complete #] subjects will participate in the study, and each individual's participation will last approximately ____[please complete with an accurate duration of participant’s time].
Study Procedures:
The study procedures include ______[State the complete study procedures for each participant, preferably in chronological order. For example, “Participation in this study will involve the following:”].
Data Collection:
This research is confidential. Confidential means that the research records will include some information about you and this information will be stored in such a manner that some linkage between your identity and the response in the research exists. Some of the information collected about you includes:[SPELL OUT SOME OF THE ELEMENTS].
[Optional Section to include, as applicable to the given project]: It is suggested to include a brief statement of what you, as the researcher, will not collect and/or have access to assure participants. For example, Android systems can allow users to get access to certain types of data (e.g., user location) but if youdo not plan to collect this type of data thenit might be helpful to state such information to participants. You might want to list items that your participants might be concerned about that the research team does not haveaccess to, such as all postings from their social media account].
App or Device Security Protections:
[Optional Section to Include, as applicable to the given project]: It is highly recommended that you set up a passcode on your own phone and/or electronic device to help prevent unauthorized access to your device and research data, especially for studies that involve collection of any private health information. It’s also recommended that aremote disable feature be set up on your device in case it’s lost or stolen. This will allow you to remotely disableor remove any apps and/or data.[Describe any protections being offered to participants so they can protect or encrypt data on the device or through the app itself].
Limits to Data Protections or Confidentiality:
[Optional Section to Include, as applicable to the given project]: In order to get access to intended or target data, the researcher might happen to get access to or can’t avoid having seen certain data. While the researcher might have or gain access to your location data, financial or other personal information on your device, this data will not extract such information. Instead, we will only extract data that has already been stated in previous paragraphs.
In some situations, it may be necessary for the researcher or research staff to break confidentiality. For example, if you threaten to harm yourself or another person or report any incidents of child or elder abuse (or if it is strongly suspected), then the investigator is required to notify the appropriate authorities. There is also the remote possibility that the research records will be subpoenaed by a court of law.[Please be aware that there are differences between paper data versus electronic data collections. As such, if electronic data is collected, this section must be expanded to state if the electronic data be stored indefinitely or if data will be wiped off of the hard drive. If yes, state simple procedures here but describe specifics in your protocol. Otherwise, revise to include any methods to be used to either collect dataanonymously or that will be used to anonymized data, such as using a unique ID number and timeframe for ‘de-linked’ the ID# from the participant’s identifying information (This might help to protect participants from having their information subpoenaed)].
Access to Research Data:
The research team and the Institutional Review Board at Rutgers University are the only parties [please modify if others will have access to the data] that will be allowed to see the data, except as may be required by law. If a report of this study is published, or the results are presented at a professional conference, only group results will be stated.
All study data will be kept for [indicate the length of time data will be retained, e.g. destroyed upon completion of the study procedures; destroyed upon publication of study results; retained indefinitely, as stated in study protocol. Per Federal Regulations it must be at least three years]. [If data is retained indefinitely, then state]: You should know that any recorded data (recordings) shall be retained for an indefinite time, but all security measures described will be maintained until recordings are destroyed.
Data Transmission & Storage:
Research data will be sent from the electronic device [or mobile app] to the research team via [Describe how data will be transmitted.If the data will be on paper forms, describe how they will be sent to the researcher. If data will be stored electronically on a server, describe which server/where and security methods to maintain privacy]. Please note that we will keep this information confidential by limiting individual access to the research data and keeping it in a secure location. The research data will be stored [MUST SPELL OUT ALL SECURE STORAGE/MAINTENANCE OF THE DATA, e.g., password protected computers, encryption methods etc.].
General Risks:
The use of technology canpresent risk(s) as part of this research project. Generally, it is possible that private data from a mobile device may be intercepted during transmission.[Describe how data is or will be transferred/ transmitted. Indicate what level of encryption will be used, if any. Describe to what extent that any identifiers will be removed). It is also possible that your data could be accessed by others should the participant lose his or her mobile device. Some additional risks are related to a loss of confidentiality, especially when using electronic devices to transmit, store and access data.
There is some possibility that others may see your open webpage or smartphone communications. In addition, certain apps or app protections may affect the battery life of the device [this needs to be disclosed to participants/included in the protocol]. Measures to protect security in these instances are described below.Any known potential loss of confidentiality will be disclosed here.
Risks of participation include:
[Describe any foreseeable risks or possible discomforts that the participation on this study might impose or have an increased impact data extraction. Otherwise, state “There are no foreseeable risks to participation in this study”]. All data transfers use commonly-used encryption protocols to protect wireless transfers so that theserisks are minimized by: [describe any planned methods, such as encryption. For example, study staff will help participants install a password on his/her smartphone to help protect his/her data in case the phone is lost].
Benefits:
You have been told that the benefits of taking part in this study may be: [please list possible benefits].However, you may receive no direct benefit from taking part in this study. You will receive ____ [please fill in or remove statement if subjects are not compensated/paid or given RU points]for completing the entire study.
Voluntariness:
Participation in this study is voluntary. You may choose not to participate, and you may withdraw at any time during the study procedures without any penalty to you. In addition, you may choose not to answer any questions with which you are not comfortable.If you decide to participate and choose to later withdraw from the study, then you may do so at any time by contacting the researcher. After withdrawing from the study, your data and/or health information will no longer be used or disclosed in the study, except to the extent that the law allows the researchers to continue using and disclosing your information.
You should be aware that the researchers may continue to use and disclose data, including your health information that was provided before you withdrew your authorization, if necessary to maintain integrity of the research or if the data had already been stripped of all identifiers. If you wish to withdraw your permission for the research use or disclosure of your data and/or health information in this study, you may do so in writing by contacting [Add researcher’s name, email address, or other contact information].
Questions about the Research:
If you have any questions about the study or study procedures, you may contact myself at [please provide your full contact information].
[ALL STUDENTSMUST INCLUDE THIS SECTION, not the above]: If you have any questions about the study or study procedures, you may contact myself at [please provide full contact information-address, email and phone number]. You may also contact my faculty advisor ____[please provide full contact information-full name, address, email and phone number].
Questions about Participant Rights:
If you have any questions about your rights as a research subject, you may contact the IRB Administrator at Rutgers, the State University of New Jersey at:
Arts & Sciences Institutional Review Board
Office of Research and Regulatory Affairs
335 George Street, Suite 3200
New Brunswick, NJ 08901-8559
Telephone: 732-235-9806
Email:
You will be given a copy of this consent form for your records.Sign below if you agree to participate in this research study:
Subject (Print) ______
Subject Signature ______Date ______
Principal Investigator Signature ______Date ______
[For Projects to be conducted ONLINE (in an electronic format/not in-person) will need to remove the signature section above and instead, include the following section which can be edited, as applicable.
If not applicable, then remove this section]:
Please retain (print) a copy of this form for your records. If you are 18 years of age or older, understand the statements above, and will consent to participate in the study, click on the "I Agree" button to begin the survey/experiment.
If you do not wish to participate in this study, then please click on the “I Do Not Agree” button which you will exit this program.
Top of Form
______
For IRB Use Only. This Section Must be Included on the Consent Form and Cannot Be Altered Except For Updates to the Version Date.
Version Date: v1.0
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